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A Phase 3 Study of the Hepcidin Mimetic Rusfertide (PTG-300) in Patients With Polycythemia Vera

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Trial Profile

A Phase 3 Study of the Hepcidin Mimetic Rusfertide (PTG-300) in Patients With Polycythemia Vera

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 17 Jun 2026

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At a glance

  • Drugs Rusfertide (Primary)
  • Indications Polycythaemia vera
  • Focus Registrational; Therapeutic Use
  • Acronyms VERIFY
  • Sponsors Protagonist Therapeutics

Most Recent Events

  • 02 Mar 2026 According to a Takeda media release, based on results form VERIFY, REVIVE and THRIVE results the U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) and granted Priority Review for rusfertide for the treatment of adults with polycythemia vera (PV). The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date in the third quarter of this calendar year.
  • 06 Jan 2026 According to a Protagonist Therapeutics media release, company announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of rusfertide for the treatment of adults with polycythemia vera (PV).
  • 06 Dec 2025 According to a Protagonist Therapeutics media release, company is looking forward to work withTakeda, to prepare for submission of an NDA to the FDA.

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